Larotrectinib Likely to Get EU Nod for NTRK+ Tumors

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of larotrectinib (Vitrakvi) for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.1

The overall response rate (ORR) with the TRK inhibitor larotrectinib was 72% (95% CI, 62-81) in the primary pooled analysis population, comprising a 16% complete response (CR) rate and 55% partial response (PR) rate. When including the primary CNS patients in the analysis, the ORR was 67% (95% CI, 57-76), comprising a 15% CR and 51% PR.
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